JP5687840B2 - Retractable needle safety blood collection device - Google Patents

Description

  The present invention generally relates to hypodermic needles. In particular, the present invention relates to a hypodermic needle device for taking a sample of blood or other body tissue that hides the sharp tip (s) of the hypodermic needle used below.

  A hypodermic needle is a sharp, hollow needle intended to pierce or pierce the skin, mucous membranes, and internal organs of humans or animals for the insertion or removal of liquid, aerosol, or particulate suspensions. is there. A hypodermic needle is commonly used with a syringe to inject a substance into the body or to withdraw fluid from the body. Such a needle may also be used to take a liquid sample from the body, for example to take blood from a vein by venipuncture.

  When a hypodermic needle enters the patient's body, it is always contaminated by the patient's blood, body fluids, and the like. With the use of syringes described below, hypodermic needles pose a risk to treatment and support physicians, nurses, and other health care workers, but they may inadvertently become infectious if the needle punctures them. Or because the illness is transferred to such staff. Others that are susceptible to infection by accidental needle puncture include cleaning workers who later throw away the trash including the hypodermic needle. Often, accidental needle sticks are trivial and remain unrecognized and are therefore untreated until more serious side effects become apparent.

  Generally, only sick patients receive therapeutic injections, but both healthy and sick are subject to blood sampling diagnosis. Because there are more healthy people than sick people, the incidence of accidental needlestick injury and microbial disease transmission is much more caused by blood collection devices than caused by syringes used for therapeutic injections to sick people Many. Furthermore, in contrast to a therapeutic syringe needle having one sharp end, the needle used to draw blood has a sharp puncture point at both ends and therefore has more opportunities for needle stick injury than a blood collection device.

  Automatic retraction of sharp tips after use by hypodermic syringe assemblies with safety engineering devices is an effective way to protect against accidental needle sticks and inadvertent microbial infections. So far, simple, inexpensive and effective retractable mechanisms have not been available or adaptable to blood collection devices. This is especially because double-ended needles cause special problems. For example, when such a retraction device is applied to a double point hypodermic needle, retraction of the distal sharp end often protrudes the proximal sharp end, creating the potential for injury. Furthermore, the needle may be screwed into the distal end of the injection barrel, which makes it difficult or impossible to retract the needle.

(Design criteria)
Improved engineering control is often one of the most effective ways to reduce occupational risk and is therefore an important component of a needle stick prevention plan. Such control includes implementing a device that reduces unnecessary use of the needle and has a safe function. Many sources have identified desirable characteristics of safety devices. [US Occupational Safety and Health Administration (OSHA) 1999c, Food and Drug Administration (FDA) 1992, Jagger et al. 1988, Chiarello 1995, Quebbeman and Short 1995, Pugliese 1998, Fisher 1999, ECRI 1999] These characteristics include: Including matters.
・ The device has no needle.
• Safety functions are an integral part of the equipment.
The device preferably functions passively (ie it does not require activation by the user). When user activation is required, the safety function can cooperate with the one-handed approach, keeping the worker's hand behind an exposed sharp object.
-The user can easily identify whether the safety function is activated.
• Safety functions cannot be deactivated and protection can be maintained during disposal.
• The device functions reliably.
-The device is easy to handle and practical.
• The device is safe and effective for patient protection.

  Although each of these properties is desirable, some are not feasible, not applicable, or not available in certain nursing situations. For example, a needle is always necessary because no substitute for skin penetration is available. Further, in some cases, a safety function that needs to be activated by the user is preferable to a passive function. Each device must be considered with its own strengths and ultimately the ability to reduce occupational accidents. The desired properties listed here should therefore only serve as a guide for device design and selection.

  In view of the foregoing, significant inventive efforts have been directed to hiding the sharp tip (s) of the hypodermic needle. One such effort is described in US Pat. No. 5,338,311 issued to the inventor of the present invention on August 16, 1994, entitled “Hyperdermic Needle Assembly”. Has been. The needle syringe assembly presents a needle holder with a hypodermic needle at its distal end. The needle holder is slidably mounted in the coaxial cavity of the plunger. To retract the needle, the taper is removed by a plunger that rotates relative to the syringe barrel. Preventing rotation of the needle holder relative to the syringe barrel and continuing to rotate the plunger raises the side arm of the needle holder up the plunger's helical slot and the needle holder Withdrawn into the coaxial cavity, the needle is hidden inside the syringe barrel. A similar device was disclosed in US Pat. No. 5,514,100 issued to the inventor of the present invention on May 7, 1996, entitled “Hypodermic Needle Assembly”.

  Other devices are described in Bio-Plexus, Inc. Punctur-Guard ™ equipment manufactured by Ventura City, California, USA. In this device, the coaxial tube is inserted inside the hypodermic needle after use and protrudes beyond the sharp tip. This avoids skin puncture with sharp bevels, but cannot prevent scratches and microbial transmission.

  A device in which the lid is activated is disclosed in US Pat. No. 5,810,775 (RE39107), Inventor Shaw, entitled “Cap Operated Rtractable Medical Device”. It was done. In Shaw, the spring is attached to the needle carrier in a compressed state by a coaxial barrel frame that is tapered inside the adapter. When the adapter cover is closed, the inner coaxial tube is pushed down to open the needle carrier, the spring is extended, and the needle carrier can be retracted into the adapter tube. The Shaw device has a number of disadvantages. First, the needle is free and can fall if the lid is open. In addition, the opening remains open at the bottom of the adapter tube, and the contaminated blood may become aerosolized upon withdrawal.

  Other attempts have been made to solve the needle stick problem, but no satisfactory solution is yet available. As an example, in US Pat. No. 5,070,885, inventor Bonaldo, entitled “Disposable Blood Collection Device”, a movable carrier for a double-ended needle is provided in the adapter. . The carrier is available via a manual switch that extends from the outside of the adapter through a longitudinal slot on the adapter. The manual switch allows the operator to push the needle carrier forward to retract the needle. Similarly, US Pat. No. 4,813,426, inventor Haber et al. And US Pat. No. 4,892,107, inventor Haber are also available and controlled through longitudinal slots on the adapter wall. And a needle carrier body frame that is controlled by a spring or manually.

  In U.S. Pat. No. 4,904,242, inventor Kulli, a tether is provided inside the needles at both ends, and the needles are pulled in by a tension spring. U.S. Pat. No. 4,984,580, inventor Wanamaker, provides a coaxial chamber in the nozzle area of the adapter that fits into a double-ended needle receptacle. The Wanamaker receptacle is surrounded by a compression spring. The spring release mechanism utilized from the window near the nozzle retracts the needle when activated.

  Needle devices and methods of use are described in US Pat. No. 5,193,552, inventor Columbias. There, the needle enters and exits the protective housing between two operating positions, in which case the housing shields the needle. Each operating position includes a releasable locking detent that serves to temporarily hold the needle in one position, and the retention force of one detent is less than the retention force of the other detent. A third position behind the position of shielding the needle in the housing is used to permanently lock the needle in the housing so that accidental reuse is not possible. The needle device can be used with a blood collection container or an injectable drug delivery container, each detachable and paired with the device during use.

  US Pat. No. 6,869,415 B2, inventor Asbaghi, provides armor that automatically covers the needle after the blood collection procedure is complete. Prior to this procedure, the protective member was constrained to the device in a proximal position to expose the needle, thus assisting in inserting the needle into the patient's vein. When the blood collection vial is locked to the device, the protective member is released and moves distally beyond the needle. As the needle is withdrawn from the patient, the protective member automatically covers the needle.

  US Pat. No. 7,357,783 B2, inventor Millerd also describes a blood collection device in which the entire needle is retracted and covered with an adapter. Initially, the needle assembly is advanced and the venipuncture needle is exposed for blood collection. Another needle protection remains fixed at the proximal end of the double-ended needle sampling. When the collection tube is pressed against the inner sample collection end, the lock is released and advanced to cover the venipuncture needle. At the end of the procedure, the sharp end of the sampling is still exposed to cause a contaminated needle stick.

  US Pat. No. 5,346,480, Inventor Hess et al., US Pat. No. 5,292,314, Inventor D'Allessio et al., US Pat. No. 5,049,136, Inventor Johnson, US Pat. 923,447, inventor Morgan, and U.S. Pat. No. 4,170,993, inventor Alvarez, are other examples of needle covering devices. The most currently used device is a hinged sheath that simply covers the external venipuncture tube or retracts the needle, but the sharp tip of the tube puncture is exposed and remains unsafe. Moreover, the majority of currently available devices are expensive and are inherently unsafe. Many devices still have the potential to cause accidental needle sticks and microbial transmission. Most devices must be dumped into costly sharp containers, which are not available or affordable for 3/4 of the world population.

US Pat. No. 5,338,311 US Pat. No. 5,514,100 US Pat. No. 5,810,775 US Pat. No. 5,070,885 US Pat. No. 4,813,426 US Pat. No. 4,892,107 U.S. Pat. No. 4,904,242 US Pat. No. 4,984,580 US Pat. No. 5,193,552 US Pat. No. 6,869,415 US Pat. No. 7,357,783 US Pat. No. 5,346,480 US Pat. No. 5,292,314 US Pat. No. 5,049,136 US Pat. No. 4,923,447 US Pat. No. 4,170,993

  One object of the present invention is to provide an inexpensive, easy to handle, fully integrated and precision engineered safety adapter device for a double-ended hypodermic needle to collect blood.

  Another object of the present invention is that after a sample is collected by the user, a hypodermic needle having a sharp end at both ends is pulled in spontaneously, and it is completely sealed, with an individual tamper-evident prevention device. It is an object to provide an engineering-safe blood collection adapter device that is fixed to a container.

  An additional object of the present invention is to conveniently position the operating point relative to the gripping surface of the blood sampler and to position the operating point sufficiently behind the needle body.

  Yet another object of the present invention is to provide a conventional double-ended hypodermic needle in which one piercing end enters the vein and with it the other end is pierced by a rubber stopper to allow the sample to be fed into the vacuum tube. It is to use. In addition to the operation of the blood collection needle, the size, shape, and structure of the blood collection needle are the same as before in many respects, except that the adapter is uniquely designed to accept and hide the full length of the double-ended needle It is.

  Additional objectives are the same blood collection methods, the same double-ended needles that have been used comfortably for years, and may have been banned in the current situation due to legal changes and safety concerns. It is to allow medical personnel to use the same sample tube. The aim is to resolve safety concerns so that the same inexpensive blood collection method and convenience can be obtained again. Thus, the safety device of the present invention is structurally different and unique, but is identical to other conventional devices that have been used for years, eliminating the need for special training for the user. Can be used in the way.

  Another object of the present invention is to design an adapter tube that locks the double-ended needle, stretches it to retract both sharp ends of the double-ended needle into the elongated body of the adapter, and extends both ends of the adapter tube. Closing is to completely hide the needle. This design adds an internal safety function to make it safe.

  In yet another object of the present invention, the safety mechanism is tamper proof and the device is intrinsically safe, which has no potential for use after skin puncture and needs to be discarded in a sharps container a second time. Means not logical.

  Another object of the present invention is to provide a container with a tamper-evident device that is configured so that the adapter itself is automatically safe and, after use, retracts a sharp hypodermic needle and locks securely. It shows that both ends of the adapter are firmly closed by simply pressing the actuator plate so as to eliminate the possibility of needle stick injury after use.

  Another object of the present invention is to provide a safety device in which the main functional elements cannot be separated from the device assembly. Otherwise, the functionality of the device cannot be used when it is actually needed.

  According to one embodiment of the present invention, the safety adapter includes a top plate, a needle holding plate, an actuator plate, and a bottom plate, which are four resin discs or plates, along with two special springs. This allows the device to be manufactured at a relatively low cost, which is of great interest to the medical industry.

  According to another embodiment, as specified by the National Institute for Occupational Safety and Health (NIOSH) and the United States Occupational Safety and Health Administration (OSHA), the retractable mechanism is a lateral surface on the locking plate at the rear end of the puncture needle. Operates by touch. In this case, the safety device instantaneously retracts the hypodermic needle and closes the opening. The dangerously sharp needles are completely and permanently enclosed in a hard, puncture-resistant, stretched resin adapter tube with both ends of the tube mechanically closed.

  In yet another aspect of the disclosed concept, in the retracted state, the needle is held concentrically with respect to the central axis of the adapter tube, with either sharp tip on the side or end housing of the tube. Do not touch.

  According to another aspect of the present invention, the mechanical closure of the distal end prevents the spread of reactive aerosolization in other retractable needle devices. Since the intra-luminal inertia of the liquid is in the opposite direction, the short end of the needle will not produce an aerosol. The square opening in the proximal plate has, for example, a roughly square shape that allows the plate to rotate for engagement and alignment with other elements.

  The foregoing features and advantages, as well as other features and advantages of the present invention, will be described in the following detailed description of the preferred embodiment and best mode for carrying out the invention with reference to the accompanying drawings and appended claims. Will be readily apparent.

  While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and are described in detail below. Of course, however, the invention is not intended to be limited to the particular forms disclosed. On the contrary, the invention includes all modifications, equivalents, and alternatives without departing from the spirit and scope of the invention as defined by the appended claims.

FIG. 1 is a perspective view of a hypodermic needle safety device according to the present invention, with a liquid sampling in a position where it is coupled to the sample inhalation end of the hypodermic needle at both ends in the extended position and the opposite sample output end of the hypodermic needle A vacuum tube is shown. FIG. 2 is an exploded plan view of a partial cross-sectional view of a hypodermic needle safety device according to the present invention. FIG. 3 is a plan view of a partial cross-sectional view of a hypodermic needle safety device according to the present invention, including not only a cross-sectional view of a liquid sampling tube to be attached, but also a cross-sectional view of attached double-ended needles. 4 is a rear view of the hypodermic needle safety device of FIG. 3, and is a partial cross-sectional view taken along line AA of FIG. 5 is a front view of the hypodermic needle safety device of FIG. 3, and is a partial cross-sectional view taken along the line BB of FIG. 6 is a side view of the hypodermic needle safety device of FIG. 3, and is a partial cross-sectional view taken along the line CC of FIG. FIG. 7 is an exploded perspective view of a hypodermic needle safety device according to the present invention. FIG. 8 is a perspective view of an exemplary needle holder or adapter according to the present invention. FIG. 9 is a rear view of the needle holder of FIG. FIG. 10 is a side view of the needle holder of FIG. 8, and is a partial cross-sectional view taken along the line DD of FIG. FIG. 11 is a front view of the needle holder of FIG. FIG. 12 is a perspective view of an exemplary top plate according to the present invention. FIG. 13 is a front view of the top plate of FIG. 14 is a side view of the top plate of FIG. 12, and is a partial cross-sectional view along the line EE of FIG. FIG. 15A is a side view of the first pressing member according to the present invention shown in a compressed state. FIG. 15B is a side view of the first pressing member of FIG. 15A shown in an extended state. FIG. 16 is a perspective view of an exemplary needle holding plate according to the present invention. 17 is a front view of the needle holding plate of FIG. 18 is a side view of the needle holding plate of FIG. 16, and is a partial cross-sectional view taken along the line FF of FIG. FIG. 19A is a side view showing the compressed state of the second pressing member according to the present invention. FIG. 19B is a side view showing the second pressing member in FIG. 19A in an extended state. FIG. 20 is a perspective view of an exemplary bottom plate according to the present invention. 21 is a rear view of the bottom plate of FIG. 22 is a side view of the bottom plate of FIG. 20, and is a partial cross-sectional view taken along the line GG of FIG. FIG. 23 is a perspective view of an exemplary actuator plate according to the present invention. FIG. 24 is a side view of the actuator plate of FIG. FIG. 25 is a perspective view of an exemplary double-ended hypodermic needle according to the present invention. FIG. 26 is a perspective view of an exemplary retraction control component according to the present invention. FIG. 27 is a front view of an exemplary hypodermic needle safety device according to the present invention showing the actuator plate in a first position and one end of a double-ended hypodermic needle extending from the distal end of the safety device. FIG. 28 is a front view of the safety device of FIG. 27, showing the hypodermic needle retracted into the actuator plate and protective adapter in the second position. FIG. 29 is a front view of the safety device of FIG. 27, a hypodermic needle in a position fully retracted into the protective adapter and a third position of the actuator plate that irreversibly closes the distal opening of the protective adapter. FIG. FIG. 30 is a plan view of an exemplary hypodermic needle safety device in accordance with an alternative embodiment of the present invention, with the outer protective adapter peeled away in partial cross-section to show a double-ended hypodermic needle encased within the adapter. Both ends are completely irreversibly closed.

  While the invention is capable of many other forms of embodiment, it is to be understood that the disclosure of the present invention should be viewed as illustrative of the principles of the invention, and the preferred embodiment of the invention is illustrated in the drawings, Having been described in detail herein, it is not intended that the broad concepts of the invention be limited to the illustrated embodiments.

  Referring to the drawings, like reference numerals refer to like elements throughout the several views of the perspective view of hypodermic needle safety device 10 depicted in FIG. The safety device 10 includes a first distal end 14 (eg, a “sample inhalation end”) of a double-ended hypodermic needle 12 protruding from an opening at the distal end of a needle holder 30 (hereinafter also referred to as “adapter”). Indicated. A liquid sampler, hereinafter referred to as vacuum tube 18, can be used to receive and sample liquid via the hypodermic needle 12 at both ends. The vacuum tube 18 shown in FIG. 1 is positioned to operably couple with the second proximal end 16 of the hypodermic needle 12 (eg, the “sample output end” shown in FIG. 2). The double-ended hypodermic needle 12 and the vacuum tube 18 are optional elements and may be supplied separately from the safety device 10 or may be included in one assembly together with the safety device 10. The shape, size, and overall structure of hypodermic needle 12 and vacuum tube 18 may also be modified individually or collectively to meet the specific design requirements of the intended application of safety device 10.

  In the illustrated embodiment, each of the two needle ends 14, 16 has a sharp / sharpened tip, represented as 20 and 22 in FIG. 2, respectively. For certain applications of the present invention, the first sharp tip 20 of the hypodermic needle 12 may be considered a “puncture end” designed to puncture / pierce through the skin, organ, vein, etc. of a human or animal. . The second sharp tip 22 may be thought of as a “distributing end” designed to dispense the liquid sample received by the sample inhaling end 14 of the hypodermic needle 12. As an example, the liquid sampling device 18 of FIG. 1 includes a cylindrical body 24 having a rubber plug 26 attached to the distal end of the cylindrical body 24 that provides a vacuum seal that is normally free of liquid leakage. In this case, the sample output end 16 of the hypodermic needle 12 can be press-fitted into the rubber stopper 22 so as to make a hole so that the liquid sample can be drawn into the tube 18 through the vacuum needle 12 in the tube 18. To work.

  With continued reference to FIG. 1, the needle holder 30 is an elongated tubular body 32 that may have a generally oval longitudinal cross section (as shown) or other design (eg, circular or elliptical perimeter). including. Needle retainer 30 includes an optional raised, jagged outer surface 34 on an opposing portion of retainer body 32. The jagged surface 34 provides the operator with a high friction, non-slip grip during use of the safety device 10. Needle holder body 32 may be manufactured from a single, single part or molded from separate parts that are subsequently assembled. Similarly, the knurled surface 34 may be pre-formed on the needle holder body 32 or may be provided as a separate additional feature that adheres or adheres to the holder body 32.

  As shown in FIGS. 5 and 9, the needle holder body 32 has a circular opening 36 at its proximal end where the sampling (vacuum) tube 18 can be used. Further, the proximal end of the needle holder 30 is provided with a pair of identical knobs, that is, a collar 38 protruding from the opposite side of the holder body 32 to the outside of the side surface. These knobs 38 provide a leverage to balance, press the vacuum tube 18 into the needle holder 30 to take a sample, and control to retract the tube 18 after obtaining a liquid sample. This process may be repeated to obtain multiple samples for different examinations.

  In the illustrated embodiment, the distal end of the adapter tube 30 has a generally oval opening 40, which is very clearly visible in FIGS. The cage main body 32 includes a plurality of side windows such as a first side window 42 and a second side window 44, which are shown in FIGS. 2, 7, and 10, respectively. In the illustrated embodiment, the windows 42 and 44 are formed through the side walls of the retainer body 32 and are offset from each other at the proximal and distal opposing surfaces of the opening 40 of the adapter tube 30. Each side window 42, 44 is configured to receive and engage each of the projections 62 and 64 of the bottom plate 60 (shown in FIG. 2). When both protrusions 62 and protrusions 64 are operably associated with the corresponding windows 42 and 44, the bottom plate 60 is locked to the adapter tube body 32 and partially seals the egg-shaped opening 40 of the adapter tube 30. It acts as a blocker.

  There are two cavities with detents 46 and 48 at the proximal end of the adjacent needle holder 30 (FIGS. 5, 8 and 11). In the illustrated embodiment, the detents 46, 48 protrude inward from the opposite side of the adapter tube body 32. These bendable detents 46, 48 may be formed in the tubular body 32 together with an internal restoring curved portion. By way of example and not limitation, the detents 46, 48 thereby have a top plate 70 (hereinafter also referred to as a "hub") at the proximal end of the tubular body 32 to seal or close the substantially circular opening 36. Is designed to selectively lock. When the top plate 70 is pushed rearwardly toward the opening 36 proximal to the adapter 30, the outer perimeter of the receptacle base 72, as will be described in more detail below, is the slope of the respective front face of the detents 46,48. Engages with surfaces 45 and 47 (FIG. 6). In doing so, the detents 46, 48 deflect outward so that the top plate 70 can pass from one side to the other. The detents 46, 48 then bend inwardly back to lock the top plate 70 in place to pin the top plate 70 between the detents 46, 48 and the inner surface of the adapter knob 38. As shown in FIG. 30, the circular opening 36 is tightly closed.

  According to the exemplary embodiment shown, the overall width W1 of the retainer body 32 shown in FIG. 4 is greater than the height H1 shown in FIG. The external dimensions of the adapter 30 are preferably uniform along the length of the tubular body 32, but the internal dimensions are intentionally made non-uniform. For example, in the illustrated embodiment, the proximal portion of the retainer body 32 has a second longitudinal section, while the distal portion of the retainer body 32 has a first longitudinal section. As an example, referring to FIGS. 4 and 5 in comparison, the inner proximal portion of the retainer body 32 is made roughly circular by two diameter inner ribs 52 and 54 (eg, along the line BB). However, the interior of the distal portion has a generally oval cross-section (eg, along the line AA). The internal shape of the adapter 30 provides a positive stopping point used to limit the retraction speed and distance of the needle holding plate 70. In other words, the non-uniform, internal shape of the tubular body 32 restricts certain retraction elements at desired locations along the length of the tubular body 32 and restricts the movement of selected components of the safety device 10. Designed to control, details are described below. In particular, the length, width, number, and direction of the diameter ribs may be changed without departing from the scope of the present invention.

  In some embodiments, the short diameter surface of the tubular body 32 proximal to its distal end allows the distal end 14 of the hypodermic needle 12 and the object (eg, patient vein) to be penetrated. Provides an ergonomically smaller angle in between. For clarity, the central axis of the needle puncture end 14 and the vein are preferably the smallest angle possible to avoid inadvertent double punctures to the vein wall. Such double puncture can cause subcutaneous hemorrhage and hematoma, which can be further exacerbated by the hemostasis applied to the arm to increase venous pressure. In addition, this portion of the adapter body 32 maintains a flat surface between the safety device 10 and the underlying vein. This is also a convenient position for obtaining multiple samples with minimal movement of the needle 12.

  In certain applications of the present invention, a predetermined portion of the adapter 30, preferably along the short diameter outer surface of the retainer body 32, securely holds the puncture end 20 of the needle 12 inserted into, for example, a vein or body cavity. Including friction lines for. As already mentioned, the distal portion of the adapter 30 has a raised, jagged surface 34 that extends in an arcuate manner along the outer surface of the retainer body 32 between the main axis and the saddle point of the oval cross section. Including. The jagged surface 34 increases the sliding friction between the tubular bodies 34 and the objects adjacent to them, thereby improving the overall control of the syringe assembly.

  Turning briefly to FIG. 25, the safety device 10 uses a double-ended hypodermic needle 12. The two ends 14, 16 of the needle 12 are formed of one, single body having opposing beveled ends and a longitudinally elongated internal channel therebetween (not specifically referred to by reference numerals, but shown in FIG. 25). It is desirable to fluidly connect the piercing end 20 and dispensing end 22 openings. According to the illustration shown, the coupler 56 is operably coupled to the hypodermic needle 12 between the distal end 14 and the proximal end 16. The coupler 56 may be insert molded into the middle portion of the hypodermic needle 12 to provide a stable, manipulable anchor for the needle 12. For example, the illustrated coupler 56 is operatively coupled (ie, screwed) to the female luer receptacle 82 that is screwed into the needle retainer plate 80, best shown in FIGS. And a male luer receptacle 57 to be screwed into.

  The coupler 56 also has a plurality of raised ridges 58 configured to lock with a needle wrap (not shown). In the embodiment illustrated in FIG. 25, the four ridges 58 project radially outward from the central receptacle portion 59. The ridge 58 is designed to press fit into the needle cover to secure the cover to the coupler 56. Further, the ridge line portion 58 preferably presses the male luer receiving port 57 against the female luer receiving port 82 and rotates the needle cover without exposing the sharp pointed ends 20 and 22, so that the hypodermic needle 12 can be moved. It locks with the needle cover so that it may be screwed into the needle holding plate 80. The double-ended needles may be manufactured in a plurality of sizes. Any dimensional discrepancy can be easily corrected by changing the length of the canola on both ends and the location of the coupler.

  The bottom or distal end of the tube 32 of the adapter 30 is substantially closed by a bottom plate 60, which is independently depicted in various respects in FIGS. The bottom plate 60 has a roughly egg-shaped base 61. In the preferred implementation, the outer perimeter of the base 61 matches the internal shape and dimensions of the distal portion of the retention tube body 32. The aligned geometry allows for proper placement and complementary engagement and essential placement of the bottom plate 60 as well as engagement of the triangular protrusions 62, 64 with the windows 42, 44 at the edges of the cage body 32. To. The bottom plate 60 may be manufactured with raised edges 66 (FIGS. 21 and 22) that extend along the outer periphery of the base 61. These edges 66 have a chamfered surface to receive the distal portion of the retainer body 32 and are shown in FIG.

  In some disclosed embodiments, the triangular protrusions 62, 64 are comprised of snap fasteners, each comprising a flexible elongated portion having a generally triangular head (each not explicitly referred to) But both are readily apparent by looking at FIG. When the bottom plate 60 is coaxially pressed into the egg-shaped opening 40 of the tubular body 32, the triangular protrusions 62, 64 are not aligned until the head of each protrusion is properly positioned with the respective window 42, 44. At that location the protrusions 62, 64 are straight and bend inward until the head fits into the window. Once properly engaged with the windows 42, 44, the head of each projection is located within the inner perimeter of the window rim and the elongated portion extends along the inside of the tubular body 32. When the protrusions 62, 64 are fully engaged, it is virtually impossible to separate the bottom plate 60 from the adapter 30 without destroying the tube 32, or to intentionally remove one part from another. Optionally, for added safety, the mating edges may be joined by solvent or ultrasonic welding.

  Bottom plate 60 is configured to receive and pass through, perforated, semi-circular anchoring bills 74 (see FIGS. 12-14) that project roughly perpendicularly from the front surface of top plate base 72. A central opening 67 having a roughly circular shape is provided. For example, when the safety device 10 is in an inactivated state as seen in FIG. 1, each anchoring protrusion 74 has a complementary pseudo-circular, crescent shaped opening 86 in the base 84 of the needle holding plate 80. Also passes. At this time, the fixing protrusion 74 is configured such that the screwed female receiving port 82 of the needle holding plate 80 is partially circumscribed in a cooperative manner. From the same point of view, when the safety device 10 is inactivated, the top plate 70 presses and pins the needle holding plate 80 between the top plate 70 and the bottom plate 60, and the female luer receptacle 82 of the needle holding plate 80. A portion passes through the central opening 67 of the bottom plate 60. Therefore, the top plate 70 and the needle holding plate 80 are held in the inactivated position by the locking engagement between the fixing protrusion 74 and the actuator plate 90 shown separately in FIGS.

  20 and 22, the bottom plate 60 has a pair of opposing L-shaped fasteners 68 that protrude normally perpendicular from the front outer surface of the base 61. In the example illustrated in FIG. 20, the fasteners 68 are formed integrally with the bottom plate 60 and are mirror images of each other. The two fasteners 68 cooperatively form a channel between them in order to attach the actuator plate 90 to the bottom plate 60 and to the adapter 30 inseparably. In the description, as shown in FIG. 1, each L-shaped fastener 68 locks the opposing sides of the actuator plate 90 and pins the plate 90 between the fasteners 68. For this locking, the actuator plate 90 is hinged to the front plate 60 so as to slide laterally relative to the adapter body 32 along its main axis (eg, from the left with respect to FIG. 1). However, any longitudinal movement along the central axis of the body 32 or lateral movement along the minor axis of the body 32 (eg, up and down with respect to FIG. 1) is limited.

  Referring back to FIG. 2, the safety device 10 further includes at least two push members, here represented by first and second helical, conical compression springs 100 and 102, respectively. In one exemplary embodiment, the first pushing member 100 is shown in FIG. 15B from the compressed state shown in FIG. 15A, which is preferably substantially flat due to the conical shape, with the spring 100 tapered. Configured to be displaced in the stretched state shown. Similarly, the second pressing member 102 is configured such that the spring 102 is preferably displaced from the substantially flat compressed state shown in FIG. 19A to the extended state shown in FIG. 19B. The two pressing members 100, 102 provide a retraction control mechanism (ie, safety device 10) that has sufficient force to retract the double-ended hypodermic needle 12 quickly and accurately. For example, maintaining a coaxial arrangement between the needle ends 14, 16 and the tubular body 32, and providing control of control of the length of linear movement of the needle 12. Furthermore, the cooperative interaction of the two pressing members 100, 102 has the function of moving the two sharp ends 20, 22 of the needle 12 to two different locations within the adapter body 32, both locations being shown, for example, in the figure. 30 between the hard, relatively robust resin end plates (ie, bottom plate 60 and top plate 70).

  In the embodiment illustrated in FIGS. 3 and 6, the top plate 70 selectively secures the hypodermic needle 12 to the base of the retainer 30 against the force of the first and second compression springs 100, 102. Let When the top plate 70 is secured at the distal end of the adapter body 32, the top plate 70 is positioned between the top plate 70 and the needle holding plate 80, for example through a locking engagement between the securing projection 74 and the actuator plate 90. The first, proximal spring 100 is compressed and pinned. This same locking engagement also acts to compress and pin the second, distal spring 102 between the bottom plate 60 and the needle retaining plate 80.

  In contrast, when the actuator plate 90 is activated, the top plate 70 is opened, as described below, toward the proximal end of the adapter body 32 by extending the first and second pressing members 100,102. Pressed. In other words, the continuous engagement of the first spring 100, the needle holding plate 80, the second spring 102, and the bottom plate 60 pushes the top plate backward relative to the adapter body 32 (eg, FIG. 3 or FIG. 6 upwards). When the retraction is complete, the top plate 70 is irreversibly locked with the adapter body 30 (eg, with flexible detents 46, 48), plugging the proximal circular opening 36 of the tube 32 and retracting both ends. Use of the proximal end 16 of the needle 12 is prevented.

  In the illustrated embodiment, the diameter of the hard, circular top plate base 72 is at the proximal end of the retainer tube 32, and first and second diameter internal ribs 52, 54 (hereinafter also referred to as "barriers"). Is larger than the circular opening 36 proximal to the adapter 30. The thickness of the top plate base 72 is approximately 0.03 inches (0.08 cm), and the edges are preferably straight and smooth so that they can move linearly up along the interior of the tube body 32. Have sufficient spacing. Top plate 70 has a central hole 76 (FIGS. 13 and 14) defined through base 72. The central hole 76 is intended to allow the second, proximal end 16 of the double-ended hypodermic needle 12 to pass through the top plate 70 (eg, as shown in FIG. 3, the puncture engages the rubber plug 26 of the vacuum tube 18). It can be so). In the illustrated example of FIG. 13, the holes 76 have a generally rectangular shape that allows the plate 70 to rotate for engagement and alignment with other elements, for example.

  As already mentioned, the two symmetrical, semicircular fixing projections 74 protrude from the front / bottom surface of the top plate base 72. The outer surface of each anchoring protrusion 74 includes a lateral anchoring notch 78 that is configured to lock the top plate 70 to the actuator plate 90. In particular, according to FIGS. 3 and 6, when the safety device 10 is in an inactivated state, the crescent-shaped opening 86 of the needle holding plate base 84, the central opening 67 of the bottom plate base 61, and FIG. An anchoring projection 74 passes through an oval, double diameter slot 92 in the actuator plate 90 best shown. In this example, the diameter D1 of the semi-circular anchoring protrusion 74 (FIG. 13) is (1) a wide oval slot 92 so that the end portion of the protrusion 74 can freely pass through the actuator plate 90, A circular portion 91 that is slightly smaller than the diameter D3 of the circular portion 93 (FIG. 29), and (2) is narrow so that the locking projection 74 can be mated and engaged along opposite ends of the actuator plate 90 and the slot 92. It is larger than the diameter D2 of (FIG. 29). For clarity and not limitation, the securing notches 78 are slotted to lock the protrusions 74 to the actuator plate 90 and thus to the bottom plate base 61 while allowing the actuator plate 90 to slide laterally. The opposite end portions of the 92 narrow portions 91 are received. When the actuator plate 90 is operatively engaged with the securing protrusion 74, the top plate 70 is restricted from moving axially toward the proximal end of the adapter 30. The fixing projection 74 slides the actuator plate 90 laterally with respect to the adapter 30 (for example, from right to left in FIG. 3), and brings the wide portion 93 of the slot 92 to a position where it fits the projection 74. The actuator plate 90 can be unlocked, whereby an upward force is applied to the top plate 70 by the first and second pressing springs 100, 102, and the upward movement of the top plate 70 Is possible.

  Referring briefly to both FIG. 3 and FIG. 26, the non-separable actuator plate 90 provided on the bottom plate 60 of the retainer 30 provides (1) a first pressing member to form a safe and compact assembly. 100, (2) the needle holding plate 80, (3) the second pressing member 102, and (4) the top plate 70 are selectively locked to the bottom plate 60.

  The actuator plate 90 preferably includes a generally rectangular, planar body 94 having rounded ends and integrally molded functional features. The height H2 of the actuator plate body 94 (FIG. 29) is preferably smaller than the height H1 of the adapter tube 32 (FIG. 6). The thickness T of the actuator plate body 94 (FIG. 24) is designed to fit perfectly with the channel plate 90 formed by the two molded L-shaped fasteners 68 of the bottom plate 60. Opposite long edges 96 of the actuator plate body 94 have chamfered ends 97 that facilitate sliding along a forward sloping L-shaped fastener 68 from the fastener 68 to two Facilitates the pressing of the actuator plate 90 against the channel formed between the fasteners 68. Once engaged, the actuator plate 90 can only move laterally (eg, from left to right as shown in FIG. 3) and cannot be removed from the bottom plate 60 or the retainer tube 32 and removed. A laterally offset short edge 98 has a raised, rounded edge with a textured surface protruding to provide a surface for reciprocal movement to both sides laterally along the bottom plate of the plate holder. Have. The added benefit of the raised end is that the tubular body 32 limits the lateral movement of the actuator plate 90 so that once engaged, it can only be pressed until one of the raised ends 98 contacts the side of the adapter 30. That is.

  In the embodiment illustrated in FIGS. 27-29, the wide portion 93 of the oval slot 92 has the same circular shape that coincides with the central opening 67 of the bottom plate 60. When the actuator plate 90 is pressed away from the center until the raised end of the short edge 98 closest to the narrow portion 91 contacts the retainer tube 32 (eg, to the left as seen in FIG. 3), the actuator plate 90 In this position, the fixing protrusion 74 of the top plate 70 has a notch 78 that is fixedly coupled to the narrow portion 91. When the narrow portion 91 is operatively aligned with the central opening 67 of the bottom plate 60, an inwardly protruding detent 95 (FIG. 25) is selectively adjacent to the outer periphery of the distal end of the tubular body 32, This prevents the operator from inadvertently moving the actuator plate 90 without actively engaging in unlocking the same object. When the actuator plate 90 is moved to the sealing opening 67, the same inwardly protruding detent 95 also acts to engage the inner periphery of the bottom plate opening 67, thereby preventing the actuator plate 90 from facing away. Prevent movement.

  Exemplary pressing members, ie, compression springs 100 and 102 of FIGS. 15A-15B and 19A-19B, each preferably have 6 to 10 circular coils, each of which is not uniform in diameter. When the spring 100 and spring 102 are fully compressed, each coil (shown in FIGS. 15A and 19A, respectively) fits inside the circumference of the adjacent large coil so that the compressed spring is flat. That is, the spring does not have any meaningful solid length or vertical height dimension. That is, the thickness of a fully compressed spring is less than or equal to the diameter of a single wire used to make the spring. In one embodiment, the springs 100, 102 are conical or shaped to generate the stretching force required to retract the needle 12, approximately 1.5 pounds (0.68 kg) or more, and to lift the various plates. Extends to a length of about 2.6 inches (6.6 cm) in a tapered state. Another desirable feature of these springs is one specific apex extension to the required specific position in the device.

  Referring back to FIG. 2, the larger, proximal outer diameter D4 of the first, proximal spring 100 is about 0.75 inches (1.91 cm), and the smaller, distal outer diameter. Diameter D5 is about 0.45 inch (1.14 cm), the wire diameter is about 0.03 inch (0.08 cm), and the free length is about 1.0 inch (2.54 cm). From a similar point of view, the smaller, proximal outer diameter D6 of the second, distal spring 102 is about 0.5 inches (1.3 cm) and the larger distal outer diameter D7 is About 0.8 inches (2 cm), with a wire diameter of about 0.03 inches (0.08 cm), a total of about 5 active coils, and a free length of about 1.85 inches (4. 7 cm). Such springs provide a force of about 1 pound (0.45 kg) to 1.5 pounds (0.68 kg) depending on the exact dimensions and materials. Although the diameter of the thin wire is reduced, a weaker spring can be made while keeping all dimensions the same.

  In the illustrated embodiment, the longer of the two push members, for example, the second, distal spring 102 of the exemplary embodiment of FIGS. 2 and 7, is the longer of the two needle ends, For example, the distal piercing end 14 of the illustrated embodiment is operable to focus on retraction into the retainer tube 30 to ensure complete retraction of the distal sharp tip 20. The base of the second spring 102 (ie, the larger, distal outer diameter portion) may be placed directly on the bottom plate 60 and is adjacent to the rear facing surface. The apex of the second spring 102 (ie, the smaller, proximal outer diameter portion) surrounds the female luer receptacle 82 of the needle retainer plate 80 and, when inactivated, surrounds the female luer receptacle 82. Surrounding the two semicircular fixing protrusions 74 of the top plate 70.

  In the fully retracted state, the needle retaining plate 80 rests between the extended first and second pressing members 100, 102 and the puncture end 14 of the needle 12 is retracted into the rigid retainer body 32. ing. If the interior of the tubular body 32 is roughly oval in cross section (i.e., the first longitudinal cross section), the adapter 30 may be pulled until the puncture end 14 of the needle 12 is fully retracted by the extension force of the second pressing spring 102. In the distal portion, an axial movement of the oval needle holding plate 80 is possible. The diameter inner ribs 52, 54 in the proximal portion of the adapter 30 provide an effective circular inner shape (ie, a second longitudinal section) that continues from the proximal end of the retainer tube 32. The oval needle retention plate 80 engages the internal ribs 52, 54 and stops at a preselected location between the two ends of the adapter 30, but this shape allows the circular top plate 70 to be fully advanced. It is possible to move the entire length of the retainer tube 32 from the distal end to the fully retracted proximal end of the adapter 30.

  The base of the first spring 100 (ie, the larger, proximal outer diameter portion) may be placed directly against the top plate 70, adjacent to the front surface thereof, and the semicircular shape of the top plate 70. The fixing protrusion 74 is surrounded. The apex of the first spring 102 (ie, the smaller, distal outer diameter portion) is adjacent to the rear facing surface needle retaining plate 80. In this arrangement, the proximal spring 100 is partially stabilized by the sample output end 16 of the needle 12. Proximal spring 100 moves plate 70 beyond detents 46, 48 and applies sufficient pressure to top plate 70 to lock plate 70 with circular opening 36.

  In certain applications of the present invention, there is a usable safety device 10 in which the actuator plate 90 is in, for example, the deactivated locked position shown in FIG. 27 (hereinafter also referred to as “first position”). Provided to end users. It may be desirable for one end of the actuator plate 90, such as the raised, rounded end of the leftmost short edge 98 of FIG. In the inactivated state, a female luer receptacle 82 screwed into the needle holding plate 80 is fully available to receive the coupler 56 of the hypodermic needle 12 at the proximal end of the adapter 30. For example, the female luer receptacle 82 is concentrically oriented in the central opening 67 of the bottom plate 60 and is visible through the central opening 67 of the bottom plate 60 at the end of the retainer tube 32. At this location, the double-ended hypodermic needle 12 can be easily screwed into the retainer plate 80, and therefore, in the safety device 10, a sufficient length of the sample inhalation end 14 is external to collect a liquid sample. It is suitable. By way of illustration and not limitation, the medical personnel can remove a safety lid (not shown) on the proximal end 16 of the double-ended needle 12, insert the connector 56 into the female luer 82, The coupler 56 is rotated to screw the needle 12 to the needle holder 80 and the needle shield covering the distal end 14 of the needle 12 is removed to expose the piercing end 22. The front end view of the safety device 10 of FIG. 27 shows the needle 12 mounted centrally and protrudes axially from the distal end of the adapter body 32.

  Continuing the above example, once the needle 12 is properly coupled to the safety device 10, the medical practitioner inserts the puncture end 22 of the needle 12 into the patient's vein and attaches the liquid sampling device to the sample output end 16 ( For example, the vacuum tube 18 of FIG. 1 is inserted through the proximal end opening 36 of the adapter 30 and is pressed against the second sharp tip 22 of the needle 12).

  When all required samples have been collected, the collection device is withdrawn and the needle 12 is withdrawn from the vein. The user then presses the patterned projection edge on the surface of the actuator plate 90, ie, the rounded end of the raised, rightmost short edge 98 of FIG. Due to the arrangement of the safety device 10, the opposite end is limited in movement by the tubular body 32, but the actuator plate 90 has only one pushable end. When the actuator plate 90 is pressed, the plate 90 moves the narrow portion 91 from the center (for example, to the left in FIG. 28) and aligns the wider portion 93 at the center with the bottom plate central opening 67 as shown in FIG. Hereinafter, also referred to as “second position”). This opens the semicircular anchoring protrusion 74 of the top plate 70, so that the compressed pressure springs 100, 102 can be extended so that the safety device instantly attaches the needle 12 to the tubular body. Pull inside. Furthermore, the top plate 70 rises toward the proximal end of the adapter 30 to fix the opening 36. During movement, the top plate 70 is displaced and passes over the heads of the detents 46, 48. Once the top plate 70 is directly adjacent to the opening 36, the plate 70 is locked between the edge of the opening 36 and the detents 46, 48 so that movement in the opposite direction is limited.

  When the plate 90 is continuously pressed, a wider semicircular portion 93 is moved from the center with respect to the bottom plate central opening 67 as shown in FIG. 29 (for example, to the left in FIG. 28) (hereinafter referred to as “third position”). "). When the actuator plate 90 is further pressed, the opening 67 is closed. The other end of the actuator plate 90, such as the raised, rounded end of the rightmost short edge 98 of FIG. 29, contacts the side of the retainer tube 32 to limit the lateral movement of the actuator plate 90. It may be desirable to do so. An actuator plate detent 95 (shown hidden in FIG. 29) currently rests on the wider, semicircular portion 93 of the oval slot 92 and prevents the actuator plate 90 from moving to the opposite side. . Therefore, the device 10 is permanently locked and does not operate. Neither the distal end 20 or 22 of the needle 12 can inadvertently puncture or prick another person. Thus, the device should not be classified as a sharp device that would otherwise be a sharps container. Alternatively, the used safety device may be disposed of in standard biological waste ("red bag"), thereby reducing disposal costs.

  Turning now to FIG. 30, similar reference numerals are used to indicate similar structures, and a plan view of an exemplary hypodermic needle safety device 10 'illustrates an alternative embodiment of the present invention. The safety device 10 'is depicted with a separate outer protective adapter 30' shown in partial cross-sectional view to illustrate a double-ended hypodermic needle 12 that is placed within the adapter 30 '. The safety device 10 'is functionally similar to the safety device 10 of FIG. However, in the alternative embodiment of FIG. 30, the adapter 30 ′ is modified to include two or more internal, elongate rails 52 ′ and 54 ′ that extend the entire length of the adapter body 32 ′ from the adapter 30 of FIG. . In the illustration shown in FIG. 30, the rails 52 ', 54' are laterally offset from each other and project inward from the opposite location of the main axis of the oval cross section of the tubular body.

  The rails 52 ', 54' are intended to provide additional structural integrity to the adapter body 32 '. The rails 52 ', 54' control movement during their retraction, and provide complementary cutouts 81 'and 83' on the edge of the needle holding plate 80 'to provide proper placement of the plate 80'. It is also configured to lock. In particular, when the needle retaining plate 80 'is pressed from the distal end toward the proximal end of the adapter 32' (ie, through extension of the compression spring 102), the longitudinal advancement of the plate 80 'causes each rail 52'. 54 'is constrained to stop in a predetermined retracted position by a wide portion (ie shoulder) 53' and 55 '. In the illustrated embodiment, for example, the distance between the two rails 52 ′, 54 ′ at the distal end of the body 32 ′ is sufficiently large so that the longitudinal unconstrained free movement of the needle holding plate 80 is possible. Wide range. However, at the shoulders 53 ′, 55 ′, the needle retaining plate 80 ′ is locked at the shoulders 53 ′, 55 ′ along the rear face of the base 81 ′ so as to limit any further longitudinal movement. The distance between the two rails 52 ′ and 54 ′ is sufficiently reduced.

  In contrast, the narrower, circular shape of the top plate 70 allows the plate 70 to continue to rise completely to near the adapter opening 36 'and secure the needle 12 in the adapter 30' safely. In other words, the diameter of the top plate base 72 is less than the distance between the two broad shoulder portions 53 ', 55'. Therefore, the longitudinal movement of the top plate 70 is not hindered by the shoulders 53 ', 55'. Optionally, the top plate 70 is manufactured with complementary notches that are shaped and sized to engage the rails 52 ′, 54 ′ and appropriate positions on the plate 70 during retraction from them. Also good.

  In another alternative embodiment, the adapter body and bottom plate may be formed as one single piece. The top plate is deformable so that it can be pressed through a smaller opening, and the open proximal end of a single part may be used to insert and assemble other internal parts.

The present invention also provides a method of assembling a protective device for securely receiving a hypodermic needle having sharp ends at both ends. In some embodiments of the present invention, the protective device includes, but is not limited to, (1) a tubular adapter, (2) an actuator plate, (3) a bottom plate, (4) a first compression spring, ( 5) includes a needle holding plate, (6) a second compression spring, and (7) a top plate. For efficient and rational assembly, the movable rotating body or linear base skeleton is provided with a vertically upstanding steel rod in the axial direction with a nested adapter shape and uniform diameter. The first stage involves squeezing and irreversibly engaging the actuator plate with the bottom plate to initiate placement of the feed element on the steel bar. The elements listed thereon are then inserted in sequence and coaxially nested on the rod. Once all the elements have been supplied, all the elements are assembled by vertical pressing, and at the same time pressing the actuator plate compresses and locks the various elements in the deactivated state. The adapter assembly is completed by insertion engagement of the upright tubular outer shell by solvent bonding.

Although the invention has been described with reference to one or more specific embodiments, those skilled in the art to which the invention pertains will have various embodiments for carrying out the invention within the scope of the appended claims. It will be appreciated that alternative designs and alternative embodiments are possible.
[Aspect 1]
A safety device for selectively receiving a needle having a first sharp end and a second sharp end,
An elongated body having a first channel opening disposed at a distance from the second channel opening and defining a longitudinally oriented channel;
A needle holder coupled to and attached to the needle, wherein the first sharp end of the needle protrudes at least partially from the first channel opening. And a second location where both the first sharp end and the second sharp end of the needle are enclosed within the body between the first channel opening and the second channel opening; A needle holder that is movably disposed in the channel so as to move between
A top plate, wherein the top plate is distal to the second channel opening and a first direction, and the top plate is proximal and at least partially plugs the second channel opening. A top plate movably disposed relative to the elongated body so as to be displaced from two directions;
An actuator plate, wherein the actuator plate maintains the needle holder in the first location and maintains the top plate in the first direction; and the needle holder is in the second position. Between a second position where the top plate is moved in the second direction and a third position where the actuator plate at least partially closes the first channel opening. An actuator plate movably coupled to the elongate body for selective displacement;
A safety device comprising:
[Aspect 2]
In the safety device according to aspect 1,
A first pressing member configured to be engaged with the needle holder and selectively press the needle holder against the second location when the actuator plate is moved to the second position. A safety device further comprising:
[Aspect 3]
In the safety device according to aspect 2,
A second pressing member configured to selectively engage the top plate in the second direction when the actuator plate is moved to the second position; Safety device provided.
[Aspect 4]
In the safety device according to aspect 3,
In the first position, the first and second pressing members are springs that maintain a compressed state between the actuator plate and the top plate through the actuator plate.
[Aspect 5]
In the safety device according to aspect 4,
The safety device wherein the first and second pressing members are each substantially flat in the compressed state.
[Aspect 6]
In the safety device according to aspect 1,
A safety device further comprising a bottom plate operably coupled to the elongate body and configured to partially seal the first channel opening.
[Aspect 7]
In the safety device according to aspect 1,
The elongate body further comprises a plurality of internal barriers configured to impede movement of the needle holder, thereby maintaining the needle holder in the second location.
[Aspect 8]
In the safety device according to aspect 1,
The elongate body further comprises a plurality of internal longitudinally elongated rails configured to engage with complementary notches formed in the needle holder;
Each of the rails includes a shoulder configured to impede movement of the needle holder, thereby maintaining the needle holder in the second location.
[Aspect 9]
In the safety device according to aspect 1,
The actuator plate is a first raised end configured to engage the elongate body, thereby restricting movement of the actuator plate in a first direction;
A second raised end configured to engage the elongate body, thereby restricting movement of the actuator plate in a second direction different from the first direction. With the end
A safety device comprising:
[Aspect 10]
In the safety device according to aspect 1,
The safety device, wherein the top plate includes a plurality of anchoring protrusions configured to lock with the actuator plate in the first position, thereby maintaining the top plate in the first direction.
[Aspect 11]
In the safety device according to aspect 1,
A safety device that defines a hole configured to pass through the second sharp end of the needle when the needle holder is in the first location.
[Aspect 12]
A method of safely retracting a hypodermic needle with sharp ends at both ends attached to a movable needle holder with respect to the adapter body of the safety device,
Moving the actuator plate from a first position to a second position, comprising:
A first pressing member moves the needle holder to an intermediate location in the adapter body;
Both of the sharp ends of the needle are located within the adapter body at a distance from its distal open end and proximal open end;
A second pressing member moves the top plate to the proximal end of the adapter body, thereby substantially closing the proximal open end;
Moving the actuator plate from the second position to a third position, comprising:
The actuator plate substantially plugs the distal open end of the adapter body;
Both of the sharp ends of the needle are concealed in the adapter body and tilted and held vertically vertically on the cage tube axis to prevent the needle from sticking into the cage tube wall; ,
Including methods.
[Aspect 13]
A liquid sampling device,
A hypodermic needle having a sharp piercing end located longitudinally away from the sharp dispensing end, and a connector interposed between the piercing end and the dispensing end;
A tubular adapter comprising a hollow body defining a channel having a distal opening located longitudinally away from a proximal opening;
A first pressing member;
A second pressing member;
A top plate comprising a base having a first diameter smaller than the smallest dimension of the channel and larger than the smallest dimension of the proximal channel opening, comprising a fastening means protruding from the base, the distal Movably disposed in the channel so as to be displaced from a distal direction adjacent the channel opening and a proximal direction where the top plate is adjacent and substantially plugs the proximal channel opening. A top plate to be
A needle holder releasably coupled to the needle coupler, the needle holder comprising a base defining a plurality of openings each configured to pass through each of the top plate securing means; The puncture and dispensing of the needle within the adapter between the proximal opening and the distal opening from a distal location where the piercing end of the injection needle protrudes from the distal channel opening A needle holder movably disposed in the channel to displace to a proximal location where both ends are encapsulated;
A bottom plate securely attached to the tubular adapter and partially closing the distal channel opening, the opening configured to pass through the top plate anchoring means and the puncture end of the needle A bottom plate with a base to define;
An actuator plate, wherein the top plate anchoring means engages the actuator plate thereby maintaining the needle holder at the distal location and maintaining the top plate in the distal direction. From the position, the top plate fixing means removes the actuator plate, the first pressing member presses the needle holder to the proximal location, and the second pressing member presses the top plate to the second position. An actuator plate slidably coupled to the bottom plate such that the actuator plate can be moved to a second position that pushes in the direction of and to a third position where the actuator plate substantially obstructs the distal channel opening;
A liquid sampling apparatus comprising:
[Aspect 14]
A safety device for selectively receiving a double-ended needle having a distal and proximal sharp end,
An elongate body having a distal channel opening disposed at a distance from the proximal channel opening and defining a longitudinally oriented channel;
A distal position where the first sharp end of the needle protrudes from the first channel opening and both the first and second sharp ends of the needle within the body between the channel openings are encapsulated. A needle holder coupled to the needle and disposed within the elongate body for movement within the channel between proximal positions;
A top plate to move within the channel between a distal position and a proximal position where the top plate is proximal and at least partially plugs the proximal channel opening; A top plate disposed within the elongate body between the needle holder and the proximal channel opening;
A locking element coupled to the elongate body for locking the needle holder and top plate in the distal position, wherein the needle holder and top plate are moved to the proximal position. A locking element movable to a position where the locking for releasing is released;
A pressing means in the elongate body for moving the needle holder and top plate to the proximal position in response to movement of the locking element to an unlocked position;
A safety device comprising:
[Aspect 15]
A retraction control component for a blood collection device comprising a needle having first and second sharp ends, comprising:
A first location coupled to the needle and attached to the needle, the first sharp end of the needle projecting at least partially from the first channel opening; the first channel opening and the second channel; A needle holder movably disposed in the channel so as to move between a first location where both the first and second sharp ends of the needle between the openings are enclosed. When,
Relative to the channel to be displaced from a first direction distal to the second channel opening and from a second direction proximal and at least partially occluding the second channel opening. A top plate configured to be movably arranged,
A bottom plate configured to partially seal the first channel opening;
An actuator plate, wherein the actuator plate maintains the needle holder in the first location and maintains the top plate in the first direction; and the needle holder includes the second Between a second position where the top plate is moved in the second direction and a third position where the actuator plate at least partially closes the first channel opening. An actuator plate movably coupled to the bottom plate for selective displacement;
A first pressing member that is engaged with the needle holder and configured to selectively press the needle holder against the second location when the actuator plate is moved to the second position; ,
A second pressing member that is engaged with the top plate and configured to selectively press the top plate in the second direction when the actuator plate is moved to the second position;
A pull-in control component comprising:

Claims (15)

A safety device for selectively receiving a needle having a first sharp end and a second sharp end,
An elongated body having a first channel opening disposed at a distance from the second channel opening and defining a longitudinally oriented channel;
A needle holder coupled to and attached to the needle, wherein the first sharp end of the needle protrudes at least partially from the first channel opening. A second location where both the first and second sharp ends of the needle are enclosed within the elongated body between the first channel opening and the second channel opening A needle holder that is movably disposed in the channel so as to move between
A top plate, wherein the top plate is distal to the second channel opening and a first direction, and the top plate is proximal and at least partially plugs the second channel opening. A top plate movably disposed relative to the elongated body so as to be displaced from two directions;
An actuator plate, wherein the actuator plate maintains the needle holder in the first location and maintains the top plate in the first direction; and the needle holder is in the second position. Between a second position where the top plate is moved in the second direction and a third position where the actuator plate at least partially closes the first channel opening. An actuator plate movably coupled to the elongate body for selective displacement;
Equipped with,
A safety device that houses the needle within the channel of the elongate body when the needle holder is moved to the second location and the actuator plate is displaced to the third position . The safety device according to claim 1,
A first pressing member configured to be engaged with the needle holder and selectively press the needle holder against the second location when the actuator plate is moved to the second position. A safety device further comprising: The safety device according to claim 2,
A second pressing member configured to selectively engage the top plate in the second direction when the actuator plate is moved to the second position; Safety device provided. The safety device according to claim 3,
In the first position, the first and second pressing members are springs that maintain a compressed state between the actuator plate and the top plate through the actuator plate. The safety device according to claim 4,
The safety device wherein the first and second pressing members are each substantially flat in the compressed state. The safety device according to claim 1,
A safety device further comprising a bottom plate operably coupled to the elongate body and configured to partially seal the first channel opening. The safety device according to claim 1,
The elongate body further comprises a plurality of internal barriers configured to impede movement of the needle holder, thereby maintaining the needle holder in the second location. The safety device according to claim 1,
The elongate body further comprises a plurality of internal longitudinally elongated rails configured to engage with complementary notches formed in the needle holder;
Each of the rails includes a shoulder configured to impede movement of the needle holder, thereby maintaining the needle holder in the second location. The safety device according to claim 1,
The actuator plate is a first raised end configured to engage the elongate body, thereby restricting movement of the actuator plate in a first direction;
A second raised end configured to engage the elongate body, thereby restricting movement of the actuator plate in a second direction different from the first direction. And a safety device having a curved end. The safety device according to claim 1,
A safety device wherein the top plate includes a plurality of anchoring protrusions configured to lock with the actuator plate in the first position, thereby maintaining the top plate in the first direction. The safety device according to claim 1,
A safety device that defines a hole configured to pass through the second sharp end of the needle when the needle holder is in the first location. A method of retracting and safely housing a hypodermic needle having sharp ends at both ends attached to a movable needle holder with respect to the elongated body of the safety device according to claim 1 ,
Moving the actuator plate from a first position to a second position, comprising:
A first pressing member moves the needle holder to an intermediate location in the adapter body;
Both of the sharp ends of the needle are located within the adapter body at a distance from its distal open end and proximal open end;
A second pressing member moves the top plate to the proximal end of the adapter body, thereby substantially closing the proximal open end;
Moving the actuator plate from the second position to a third position, comprising:
The actuator plate substantially plugs the distal open end of the adapter body;
Both of the sharp ends of the needle are concealed in the adapter body and tilted and held vertically vertically on the cage tube axis to prevent the needle from sticking into the cage tube wall; ,
Including methods. A liquid sampling device,
A hypodermic needle having a sharp piercing end located longitudinally away from the sharp dispensing end, and a connector interposed between the piercing end and the dispensing end;
A tubular adapter comprising a hollow body defining a channel having a distal opening located longitudinally away from a proximal opening;
A first pressing member;
A second pressing member;
A top plate comprising a base having a first diameter smaller than the smallest dimension of the channel and larger than the smallest dimension of the proximal channel opening, comprising a fastening means protruding from the base, the distal Movably disposed in the channel so as to be displaced from a distal direction adjacent the channel opening and a proximal direction where the top plate is adjacent and substantially plugs the proximal channel opening. A top plate to be
A needle holder releasably coupled to the needle coupler, the needle holder comprising a base defining a plurality of openings each configured to pass through each of the top plate securing means; The puncture and dispensing of the needle within the adapter between the proximal opening and the distal opening from a distal location where the piercing end of the injection needle protrudes from the distal channel opening A needle holder movably disposed in the channel to displace to a proximal location where both ends are encapsulated;
A bottom plate securely attached to the tubular adapter and partially closing the distal channel opening, the opening configured to pass through the top plate anchoring means and the puncture end of the needle A bottom plate with a base to define;
An actuator plate, wherein the top plate anchoring means engages the actuator plate thereby maintaining the needle holder at the distal location and maintaining the top plate in the distal direction. From the position, the top plate fixing means removes the actuator plate, the first pressing member presses the needle holder to the proximal location, and the second pressing member presses the top plate to the second position. An actuator plate slidably coupled to the bottom plate such that the actuator plate can be moved to a second position that pushes in the direction of and to a third position where the actuator plate substantially obstructs the distal channel opening;
A liquid sampling apparatus comprising: A safety device for selectively receiving a double-ended needle having a distal and proximal sharp end,
An elongate body having a distal channel opening disposed at a distance from the proximal channel opening and defining a longitudinally oriented channel;
And a distal position in which the first sharp end of the needle protrudes from the channel opening of the distal, both of the first and second sharp ends of the elongated needle in the body between the two channel openings A needle holder coupled to the needle and disposed within the elongate body for movement within the channel between a proximal position in which is encapsulated;
A top plate to move within the channel between a distal position and a proximal position where the top plate is proximal and at least partially plugs the proximal channel opening; A top plate disposed within the elongate body between the needle holder and the proximal channel opening;
Said needle holder and said top plate a locking element coupled to the elongate body for locking in position of the distal, said needle holder and said top so as to move the position of the proximal A locking element movable to a position where the locking for releasing the plate is released;
And pressing means of the elongate body for in response to movement of the locking is disengaged positions for moving the needle holder and the top plate to the position of the proximal of said locking element,
Equipped with,
A safety device that houses the needle within the channel of the elongate body when the needle holder is in the proximal position and the top plate is in the proximal position . A retraction control component for a blood collection device comprising a needle having first and second sharp ends, comprising:
A first location coupled to the needle and attached to the needle, the first sharp end of the needle projecting at least partially from the first channel opening; the first channel opening and the second channel; A needle holder movably disposed in the channel so as to move between a first location where both the first and second sharp ends of the needle between the openings are enclosed. When,
Relative to the channel to be displaced from a first direction distal to the second channel opening and from a second direction proximal and at least partially occluding the second channel opening. A top plate configured to be movably arranged,
A bottom plate configured to partially seal the first channel opening;
An actuator plate, wherein the actuator plate maintains the needle holder in the first location and maintains the top plate in the first direction; and the needle holder includes the second Between a second position where the top plate is moved in the second direction and a third position where the actuator plate at least partially closes the first channel opening. An actuator plate movably coupled to the bottom plate for selective displacement;
A first pressing member that is engaged with the needle holder and configured to selectively press the needle holder against the second location when the actuator plate is moved to the second position; ,
A second pressing member that is engaged with the top plate and configured to selectively press the top plate in the second direction when the actuator plate is moved to the second position;
A pull-in control component comprising: